Calcium Gluconate

Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established. • Calcium Gluconate in Sodium Chloride Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. (1) • Limitations of Use: The safety of Calcium Gluconate Injection for long term use has not been established. (1)

• Administer intravenously (bolus or continuous infusion) via a secure intravenous line • See Full Prescribing Information (FPI) for administration rates, and appropriate monitoring • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use
• Any unused portion should be discarded • Individualize the dose within the recommended range
• In adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia
• See Table 1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. • Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. • Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate
• Precipitation may result if mixed
• See FPI for all drug incompatibilities
• Important Administration Instructions See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection
• Table 1. …

Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution available as: Injection: • Calcium gluconate 1,000 mg per 50 mL (20 mg/mL) single-dose bags • Calcium gluconate 2,000 mg per 100 mL (20 mg/mL) single-dose bags Injection: • Calcium gluconate 1,000 mg per 50 mL (20 mg/mL) single-dose bags (3) • Calcium gluconate 2,000 mg per 100 mL (20 mg/mL) single-dose bags (3)

• The safety and effectiveness of Calcium Gluconate in Sodium Chloride Injection have been established
• In pediatric patients
• For the treatment of acute, symptomatic hypocalcemia
• Pediatric approval for Calcium Gluconate in Sodium Chloride Injection, including doses, is not based on adequate and well-controlled clinical studies
• Safety and dosing recommendations
• In pediatric patients are based on published literature and clinical experience [see Dosage and Administration ] . …

In general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Inform patients of the risks associated with infusion of Calcium Gluconate in Sodium Chloride Injection including local tissue inflammation, local necrosis and calcinosis. [see Warnings and Precautions ]
• Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Switzerland Patented
• See www.wgcriticalcare.com/patents Novaplus is a registered trademark of Vizient, Inc. novapluse logo image

Calcium Gluconate in Sodium Chloride Injection is contraindicated in: •Hyperca lcemia • Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2)] • Hypercalcemia (4) • Neonates (28 days of age or younger) receiving ceftriaxone (4)

• Cardiac Glycoside : Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. (7.1) • Calcium Channel Blockers : Administration of calcium may reduce the response. (7.2) • Drugs that may cause hypercalcemia: Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. Monitor plasma calcium concentrations in patients taking these drugs concurrently. (7.3) 7.1 Cardiac Glycosides Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective in the presence of hypocalcemia. …

• Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, Calcium Gluconate in Sodium Chloride Injection should be given slowly in small amounts and close ECG monitoring is recommended (5.1) • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Do not administer ceftriaxone simultaneously with Calcium Gluconate in Sodium Chloride Injection via a Y-site in any age group. Cases of fatal outcomes in neonates have occurred. …

The following serious adverse reactions are also described elsewhere in the labeling: • Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1)] • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2)] • Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.3)] • Hypotension, Bradycardia, and Cardiac Arrhythmias [see Warnings and Precautions (5.4)] • Aluminum toxicity [see Warnings and Precautions (5.5)] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. …

8.1 Pregnancy Risk summary Limited available data with Calcium Gluconate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see Clinical Considerations] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. …

Overdosage of Calcium Gluconate in Sodium Chloride Injection may result in hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥12 mg/dL. Neurologic symptoms include depression, weakness, fatigue, and confusion at lower levels, with patients experiencing hallucinations, disorientation, hypotonicity, seizures, and coma. Effects on the kidney include diminished ability to concentrate urine and diuresis. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.